For several reasons, adverse events associated with medical and non-medical products need to be identified and reported. In the pharmaceutical sector, for example, safety testing typically goes through several phases prior to medicine being made commercially available, either as a prescribed medication or for over-the-counter consumer purchase. Indeed, safety studies are required for medical and related products such as drugs, biologicals, medical devices and cosmetics in order to receive approval from Federal agencies such as the Food and Drug Administration (“FDA”) to release such products to market. However, vigilance in identifying safety issues continues throughout the market life of such products. Post-marketing vigilance, however, is less formal and normally involves voluntary reporting of potential adverse events by the professionals who become aware of an event. Manufacturers in the medical and pharmaceutical sectors are required to disclose true adverse events caused by their products to the FDA. However, because there can be uncertainty as to whether a given adverse event was caused by a product or not, investigations must be taken to explore the event with persons knowledgeable of the circumstances.
In one approach described in U.S. Pat. No. 6,952,695, a system manages the input of reported adverse event information using a hierarchically structured set of predefined terms to guide the user (presumably, a physician) in the data entry. The system of the '695 patent categorizes and characterizes the reported information and dynamically converts it into a standardized output that can be stored.
In many sectors including the pharmaceutical sector, field representatives have assigned territories and knowledge of the prescribing habits of the doctors and health care professionals in their territories and are in an advantageous position to capture and forward any adverse events to the pharmaceutical manufacturer for investigation and reporting, as appropriate. Tools are needed to assist field representatives in capturing any adverse event information that they may become of aware of in connection with a site visit to a physician, and to facilitate ensuring that such information is brought to the attention of the pharmaceutical manufacturer for investigation and reporting, as appropriate, in a timely manner. The present invention addresses this need and others.